Presentation at Veith Symposium 2016, New York Title: A New Device To Simplify f/b-EVAR Speaker: Krister Liungman Content: f/b-EVAR is far from EVAR, Simplified f/b-EVAR, Guidewire fixator, 2 vessel f-EVAR in pig model,

1. A New Device To Simplify f/b-EVAR
A Guidewire Fixator: How It Works, Advantages And
Limitations
MD PhD Krister Liungman
MSc Linus Bosaeus
MD PhD Assoc Prof Kevin Mani
MD Prof Anders Wanhainen

2. Disclaimer
❑ I have the following potential conflicts of interest to report:
❑ Receipt of grants/research support
❑ Receipt of honoraria and travel support
❑ Participation in a company sponsored speakers‘ bureau
❑ Employment in industry
✓ Shareholder in a healthcare company
❑ Owner of a healthcare company
❑ I do not have any potential conflict of interest

3. Problem: f/b-EVAR is far from EVAR
Retrospective single centre cohort
study
Uppsala University Hosptial
• 63 EVAR and 63 f/b-EVAR
(2012-2015)
• Grouped by # of catheterised
branches/fenestrations/scallops
Variable EVAR 2f/b-EVAR 3f/b-EVAR 4f/b-EVAR
Fluoroscopy (min)
30.3 / 10.1-102.8 82.0 / 37.2-237.8 102.5 / 52.2-174.9
151.5 / 91.2-
289.9
DAP (mGym2) 22.5 / 1.8-132.0 26.1 / 9.6-79.3 39.9 / 11.3-89.3 52.0 / 20.4-93.9
Contrast Iodine (g) 30.9 / 8-72 42.8 / 14-115 51.6 /23-132 78.4 / 28-148
Anaesthesia (min) 181 / 60-405 340 / 180-645 458 / 255-750 628 / 510-885
Blood loss (ml) 256 / 0-1500 1352 / 150-5500 1726 / 100-5500 2379 / 650-4900
Proc. Duration (min) 141 / 70-349 392 / 250-724 476 / 213-900 559 / 383-752
Days at ICU 0.3 / 0-8 0.5 / 0-6 1.6 / 0-18 5.9 / 0-43
Days at hospital 5.1 / 1-27 6.7 / 2-26 11.4 / 2-40 17.4 / 4-46
Mean / range

4. Problem: f/b-EVAR is far from EVAR
• Conclusion
– Linear relationship between # of catheterisations and procedure variables
– f/b-EVAR is still far from EVAR and the general vascular surgeon
→ Challenge: Finding the branch and gaining sheath access
0
50
100
150
200
250
300
Fluoroscopy (minutes)
2 f/b-EVAR 3 f/b-EVAR 4 f/b-EVAR
200
300
400
500
600
700
800
Procedure duration (minutes)
2 f/b-EVAR 3 f/b-EVAR 4 f/b-EVAR

5. Can f-EVAR be done simple, stepwise
predictable?

6. Simplified f/b-EVAR
New approach to simplify catheterisation and sheath access:

7. Simplified f/b-EVAR
New approach to simplify catheterisation and sheath access:
• “Guidewire anchor” is deployed in the branches before stentgraft insertion

8. Simplified f/b-EVAR
New approach to simplify catheterisation and sheath access:
• “Guidewire anchor” is deployed in the branches before stentgraft insertion
• Retrograde lining of branch wires – on table

9. Simplified f/b-EVAR
New approach to simplify catheterisation and sheath access:
• “Guidewire anchor” is deployed in the branches before stentgraft insertion
• Retrograde lining of branch wires – on table
• Railroad graft in place over multiple wires

10. • Target vessel catheterisation post stentgraft deployment – Eliminated completely
• Less need for perfect alignment to achieve wire connection
• Sheath access improved by traction through tension
Simplified f/b-EVAR
”Lead the way
traction”

11. Guidewire fixator
• Novel device – Guidewire fixator 0,035” + stopper
• Provide distal fixation while maintaining blood flow
• Freely movable over the guidewire
• Clinical study at Uppsala University, CE approved 2016
Possible through New device

12. • Moderate radial force at rest, increases with tension
• Blood flow maintained
• Enables
– secure guidewire position,
– parallel work,
– stiffness through tension,
– Arteries 5-13 mm diameter
New tool – Guidewire fixator
14mm 11mm 8mm

13. In action - 2 vessel f-EVAR in pig model

14. Advantages & limitations
Limitations and risks
• Arterial injuries to be studied further
– Thrombosis
– Dissection
– Rupture
• Requires wire management

15. Advantages & limitations
Advantages & Potential benefits
• Stepwise, predictable
• Shorter duration
• Reduced radiation and contrast
• Anchoring allows Tension on GW
• Could be combined with filter
functionality TAAA

16. Summary and perspectives
A Guidewire Fixator - CE-approved
Feasibility trial of fenestrated technique
Other clinical applications?